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Titolo:
Pharmacokinetics of cyclosporine in monkeys after oral and intramuscular administration: relation to efficacy in kidney allografting
Autore:
Schuurman, HJ; Slingerland, W; Mennninger, K; Ossevoort, M; Hengy, JC; Dorobek, B; Vouderscher, J; Ringers, J; Odeh, M; Jonker, M;
Indirizzi:
Novartis Pharma AG, Transplantat Res, CH-4002 Basel, Switzerland Novartis Pharma AG Basel Switzerland CH-4002 CH-4002 Basel, Switzerland
Titolo Testata:
TRANSPLANT INTERNATIONAL
fascicolo: 5, volume: 14, anno: 2001,
pagine: 320 - 328
SICI:
0934-0874(200109)14:5<320:POCIMA>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
MONOCLONAL-ANTIBODY; NONHUMAN-PRIMATES; RHESUS-MONKEYS; CARDIAC TRANSPLANTATION; CYNOMOLGUS MONKEYS; BONE-MARROW; PIG; XENOTRANSPLANTATION; REJECTION; SURVIVAL;
Keywords:
cyclosporine; cynomolgus monkey; kidney transplantation; neoral; pharmacokinetics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
32
Recensione:
Indirizzi per estratti:
Indirizzo: Schuurman, HJ Immerge BioTherapeut, Bldg 75,3rd Ave, Charlestown, MA 02129USA Immerge BioTherapeut Bldg 75,3rd Ave Charlestown MA USA 02129
Citazione:
H.J. Schuurman et al., "Pharmacokinetics of cyclosporine in monkeys after oral and intramuscular administration: relation to efficacy in kidney allografting", TRANSPLAN I, 14(5), 2001, pp. 320-328

Abstract

In cynomolgus and rhesus monkeys, the dose-normalized exposure of cyclosporine administered orally as microemulsion preconcentrate (Neoral) was lowerthan that upon intramuscular administration. For oral administration, meanvalues (+/- SD) of C-max, 24-h area-under-the curve (AUC) and 24-h trough level, all normalized for a 1 mg/kg dose, were 20 +/-9 ng kg/mg ml, 210 +/-70 ng h kg/mg ml and 2.6 +/-0.9 ng kg/mg ml, respectively. For intramuscular administration, levels were about 5.5-fold, 9-fold and 22-fold higher. Based on pharmacokinetic data, the efficacy of oral cyclosporine treatment (without any other immunosuppressant) was evaluated in life-supporting cynomolgus monkey kidney allotransplantation. Rejection-free kidney allograft survival could be achieved using oral cyclosporine monotherapy with average 24-h trough concentrations above 100 ng/ml during maintenance treatment. Typically, daily oral doses of 100 mg/kg-150 mg/kg during the first two weeks post-transplantation, followed by daily 30 mg/kg-100 mg/kg dose levels during subsequent maintenance can result in long-term allograft survival, with 24-h average trough levels in individual animals during maintenance between110 ng/ml and 700 ng/ml.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/01/20 alle ore 20:02:02